Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy
Summary
A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.
Timeline
- Start
- 2021-07-07
- Primary completion
- 2023-11-08
- Completion
- 2023-11-08
Outcome
Met primary endpoint
paper The RNS60 groups met the primary end points with similar rates of serious adverse events (33.3%, 25.0%, and 28.6%) PMID 40671649 ↗
release “RNS60 met its primary endpoints in RESCUE (safety and mortality)” revalesio.com ↗
release “The RESCUE trial met its primary endpoints” revalesio.com ↗
Publications
- Results Ghosh S, Dubow JS, Sutherland J, Smith W, Chiu D, Clark WM, Favilla CG, Ansari SA, Kalmes A, Mock J, Cook DJ, Madsen TE, Jayaraman M, Moldovan K, Torabi R, Liebeskind DS, Fisher M, McTaggart RA. Randomized, Proof-of-Concept Trial (RESCUE) of RNS60 as an Adjunct Therapy in Acute Ischemic Stroke. Stroke. 2025 Sep;56(9):2386-2397. doi: 10.1161/STROKEAHA.125.051179. Epub 2025 Jul 17.
- Ghosh S, Dubow J, Favilla CG, Sutherland J, Kalmes A, Mock J, Chiu D, Clark WM, Ansari SA, Nicodemus-Johnson J, Anderson L, Liebeskind DS, Fisher M, McTaggart RA. RNS60 RESCUE Trial in Acute Ischemic Stroke: Post Hoc Analysis in Participants Enrolled <12 Hours Since Last Known Well. Stroke Vasc Interv Neurol. 2026 Apr 9;6(3):e002196. doi: 10.1161/SVIN.125.002196. eCollection 2026 May.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RNS60 | Other / unclassified | 0.5 unknown | — |
| Subject | RNS60 | Other / unclassified | 1 unknown | — |